N-acetyl Cysteine for the Prevention of Oral Mucositis After Autologous Hematopoietic Cell Transplantation.

Efficacy and Safety of N-acetyl Cysteine for the Prevention of Oral Mucositis After High-dose Chemotherapy and Autologous Hematopoietic Cell Transplantation: a Phase III, Randomized, Open Label, Multi-center Study.

Oral mucositis (OM) is a major source of morbidity in patients undergoing hematopoietic cell transplantation (HCT). N-acetyl cysteine (NAC) is an antioxidant, widely used as mucolytic agent or antidote of acetaminophen overdose hepatotoxicity. we intend to explore the safety and efficacy of NAC in the prevention of OM after high-dose chemotherapy and autologous HCT in a phase III, randomized, open label and multi-center study.

Inclusion Criteria:

• Patients with multiple myeloma and lymphoma in partial response and complete remission.
• Undergoing high-dose chemotherapy with autologous transplantation.

Exclusion Criteria:

• Known sensitivity to NAC